Iberogast and the PPI were significantly more effective than placebo

Iberogast vs Proton Pump Inhibitor
The
To view Professor Holtmann's presentation of the trial results
and to find out more about the clinical benefits of Iberogast for
the treatment of FD and IBS, visit: www.flordis.com.au/hcp
RESULTS
ARE IN
Could this Australian NHMRC^ funded trial influence the
way you manage patients with Functional Dyspepsia?
Iberogast® is registered for the treatment
of gastric and abdominal discomfort
associated with functional and
motility-conditioned gastrointestinal
conditions e.g. Functional Dyspepsia (FD)
and Irritable Bowel Syndrome (IBS).
® Registered trademark of Steigerwald Arzneimittelwerke GmbH, Germany. Flordis Pty Ltd.
PO Box 1027, Crows Nest, NSW, 1585. FLO000217 SFI6456 05/13
1. Wang, WH et al Clin Gastro & Hepato 2007;5: 178-185
2. Gundermann, KJ et al Advances in Natural Therapy 2003; Vol 20 (1) Jan-Feb :43-49
3. A Placebo Controlled Randomised Treatment Trial for Functional Dyspepsia Including Post-Treatment Drug Withdraw
and Placebo Withdraw Effects. Holtmann, G et al. Digestive Disease Week 2013, Orlando, USA, Abs Mo2071
^National Health and Medical Research Council
The Results:
This NHMRC Funded Study looked at
the key issues facing the treatment
of Functional Dyspepsia (FD)
3
Active therapy response rate was significantly
higher compared to placebo*
%
80
• Could a natural medicine, Iberogast (STW-5), be
®
• Does Iberogast significantly improve symptoms in
regular Australian FD patients?
Treatment response rate
as effective as a Proton Pump Inhibitor (PPI) for the
management of FD?
Professor Gerald Holtmann,
Director of the Department of
Gastroenterology and Hepatology,
Princess Alexandra Hospital
• What is the impact of long term use of PPIs in FD?
PPI
70
Iberogast
60
56%
63%
50
Iberogast
&
PPI
43%
40
Placebo
30
24%
20
10
0
n = 25
n = 27
n = 30
n = 28
* p = 0.05
%
80
Study Outline
• This trial group consisted of 110 patients
with FD who were divided into 4 arms
enabling comparisons between:
- Placebo
60
PPI
50
47%
30
20
- PPI (esomeprazole)
10
- Iberogast and PPI
• Gastrointestinal Symptoms Score (GIS)
was used to validate the intensity of the FD
symptoms after 2 and 4 weeks of treatment.†
• Past clinical trials have indicated that PPIs and
some natural medicines may be effective for
the treatment of patients with FD 1, 2 however,
there are no published studies which compare
natural medicines and PPIs or a combination
of both against placebo.
• In addition to the response rate, the relapse
rates were studied after switching patients
to placebo for another 2 weeks.
58%
40
- Iberogast
• This ground breaking study was conducted
through the University of Adelaide, and
completed in 2012.
Iberogast
Placebo
0%
7%
0
n=6
n = 19
n = 15
n = 12
p = 0.05
Post treatment, active therapy was replaced by placebo. The relapse rate was measured after 2 weeks of
placebo treatment.
^
Conclusions:
3
•
Iberogast and the PPI were significantly more effective than placebo (p<0.05) and have
similar response rates during a 4 week treatment period.
•
•
The difference between the effectiveness of Iberogast and the PPI was not significant.
•
† i.e during treatment from baseline to week 2 or from week 2 to week 4.
Iberogast
&
PPI
70
Relapse rate
• This independent trial was initiated and
conducted under the joint guidance of
Professor Gerald Holtmann, Director of
the Department of Gastroenterology and
Hepatology, Princess Alexandra Hospital,
and Professor of Medicine at University of
Queensland, and Associate Professor Jane
Andrews, Royal Adelaide Hospital.
Relapse rate was significantly higher with the PPI treatment
compared to Iberogast treatment^
Relapse rates were significantly higher after cessation of active therapy with the PPI
compared to Iberogast.
Combining Iberogast and the PPI did not yield an augmented response rate, however,
relapse rates were higher as compared to Iberogast alone.
The Results:
This NHMRC Funded Study looked at
the key issues facing the treatment
of Functional Dyspepsia (FD)
3
Active therapy response rate was significantly
higher compared to placebo*
%
80
• Could a natural medicine, Iberogast (STW-5), be
®
• Does Iberogast significantly improve symptoms in
regular Australian FD patients?
Treatment response rate
as effective as a Proton Pump Inhibitor (PPI) for the
management of FD?
Professor Gerald Holtmann,
Director of the Department of
Gastroenterology and Hepatology,
Princess Alexandra Hospital
• What is the impact of long term use of PPIs in FD?
PPI
70
Iberogast
60
56%
63%
50
Iberogast
&
PPI
43%
40
Placebo
30
24%
20
10
0
n = 25
n = 27
n = 30
n = 28
* p = 0.05
%
80
Study Outline
• This trial group consisted of 110 patients
with FD who were divided into 4 arms
enabling comparisons between:
- Placebo
60
PPI
50
47%
30
20
- PPI (esomeprazole)
10
- Iberogast and PPI
• Gastrointestinal Symptoms Score (GIS)
was used to validate the intensity of the FD
symptoms after 2 and 4 weeks of treatment.†
• Past clinical trials have indicated that PPIs and
some natural medicines may be effective for
the treatment of patients with FD 1, 2 however,
there are no published studies which compare
natural medicines and PPIs or a combination
of both against placebo.
• In addition to the response rate, the relapse
rates were studied after switching patients
to placebo for another 2 weeks.
58%
40
- Iberogast
• This ground breaking study was conducted
through the University of Adelaide, and
completed in 2012.
Iberogast
Placebo
0%
7%
0
n=6
n = 19
n = 15
n = 12
p = 0.05
Post treatment, active therapy was replaced by placebo. The relapse rate was measured after 2 weeks of
placebo treatment.
^
Conclusions:
3
•
Iberogast and the PPI were significantly more effective than placebo (p<0.05) and have
similar response rates during a 4 week treatment period.
•
•
The difference between the effectiveness of Iberogast and the PPI was not significant.
•
† i.e during treatment from baseline to week 2 or from week 2 to week 4.
Iberogast
&
PPI
70
Relapse rate
• This independent trial was initiated and
conducted under the joint guidance of
Professor Gerald Holtmann, Director of
the Department of Gastroenterology and
Hepatology, Princess Alexandra Hospital,
and Professor of Medicine at University of
Queensland, and Associate Professor Jane
Andrews, Royal Adelaide Hospital.
Relapse rate was significantly higher with the PPI treatment
compared to Iberogast treatment^
Relapse rates were significantly higher after cessation of active therapy with the PPI
compared to Iberogast.
Combining Iberogast and the PPI did not yield an augmented response rate, however,
relapse rates were higher as compared to Iberogast alone.
Iberogast vs Proton Pump Inhibitor
The
To view Professor Holtmann's presentation of the trial results
and to find out more about the clinical benefits of Iberogast for
the treatment of FD and IBS, visit: www.flordis.com.au/hcp
RESULTS
ARE IN
Could this Australian NHMRC^ funded trial influence the
way you manage patients with Functional Dyspepsia?
Iberogast® is registered for the treatment
of gastric and abdominal discomfort
associated with functional and
motility-conditioned gastrointestinal
conditions e.g. Functional Dyspepsia (FD)
and Irritable Bowel Syndrome (IBS).
® Registered trademark of Steigerwald Arzneimittelwerke GmbH, Germany. Flordis Pty Ltd.
PO Box 1027, Crows Nest, NSW, 1585. FLO000217 SFI6456 05/13
1. Wang, WH et al Clin Gastro & Hepato 2007;5: 178-185
2. Gundermann, KJ et al Advances in Natural Therapy 2003; Vol 20 (1) Jan-Feb :43-49
3. A Placebo Controlled Randomised Treatment Trial for Functional Dyspepsia Including Post-Treatment Drug Withdraw
and Placebo Withdraw Effects. Holtmann, G et al. Digestive Disease Week 2013, Orlando, USA, Abs Mo2071
^National Health and Medical Research Council